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InkWell Health

Inkwell Health Ltd · Model LGRKNEE-MTT-3KT · UDI-DI 10860010334574

FZZ
10
510(k) clearances
185
Adverse events
2
Recalls
183
Facilities

Description

Large Right Knee Temporary 3 Month Kit

Recalls

DateFirmReason
2013-07-10Precision Dynamics CorporationPDC Healthcare initiated this recall of Non-Sterile Viscot Part Number 1437-100 Surgical Skin Markers, becuase they were inadvertently mislabeled as PN STER-VIS Sterile Skin Marker
2012-08-22Viscot Medical LLCDual Tip Marker has inconsistent ink flow on the black permanent ink side.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.